Conflict of interest in Ireland’s drug regulator, the IMB.

Drug regulator ‘risks conflict of interest’

Gabrielle Monaghan

Ireland’s drug regulator has been accused of being too close to the pharmaceutical industry. An academic report has concluded that more than one-in-four senior personnel at the Irish Medicines Board (IMB) had “potential conflicts of interest”.

Orla O’Donovan, one of its authors, said public concern about the safety of drugs, such as swine-flu vaccines, could be alleviated if the IMB was more open about the relationship between its decision-makers and advisers and the drugs industry.

The report, published in Social Science & Medicine, showed a chairperson of one of the IMB’s advisory committees had taken part in research sponsored by the pharmaceutical industry and received industry honoraria and consultancy fees.

A former chief executive worked for a drug company before joining the IMB and left to work for another one.

Between 1996, when the agency was set up, and 2005, four members of the IMB’s senior management team had a background in the pharmaceutical industry and one of those also participated in research funded by drug companies, the research found. In total, five out of 19 senior people had links with the drug industry.

The IMB, a state body that charges pharmaceutical and medical devices companies for inspections of drugs, says no staff members have any drug company connections. It said advisory committees, which it does not regard as staff, do not make decisions.

The IMB said employees are not allowed to have any interest in the drug industry and are prohibited from working on products they have been involved with. “Products are licensed purely on the basis of their potential benefit to health,” an IMB spokeswoman said.

The study says the Irish Medicines Board Act of 1995, which set up the agency, is unclear about the “beneficial interest” committee members must declare, such as receiving honoraria from companies or serving on an advisory committee.

The study compares policies at the IMB with those of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency. It found all three operate on the assumption that potential conflicts of interest can be managed and are therefore not a problem.

O’Donovan gave the example of a 2002 IMB newsletter which announced that Professor Frank Hallinan, a former Schering-Plough employee, had resigned as chief executive and would be joining Wyeth Biopharma as director of quality. Pat O’Mahony, his successor, worked as a technical manager in the veterinary pharmaceutical industry in Ireland and the UK.

O’Donovan’s study showed that public access to information about potential conflicts of interest of senior IMB personnel and advisers is restricted.

Drugs regulator to publish declarations of interest

THE STATE’S drugs regulator is planning to provide public access for the first time to the declarations of interest of its staff, board and committee members in pharmaceutical companies.

The Irish Medicines Board, which licenses new drugs and medical devices, plans to bring its practices into line with the European Medicines Agency, which publishes such declarations online, The Irish Times understands.

The agency yesterday rejected claims in an academic journal that senior people working in or with the IMB face potential conflicts of interest as a result of past links to the pharmaceutical industry.

Orla O’Donovan of UCC’s department of applied social studies, writing in the journal Social Science Medicine, claimed the agency “manages” rather than prohibits potential conflicts of interest and restricts public access to information on the issue.

Writing in the same journal, Prof John Abraham of the University of Sussex described the lack of public access to the declaration of interests by committee members as “shocking” and “an unacceptable democratic deficit in modern Europe”.

IMB rules prohibit staff or their families from having any financial interest in the pharmaceutical industry and from working on products that they may have had an involvement with in previous employment. Members of advisory committees are asked to confirm at each meeting that they have no conflict with matters under discussion.

However, declarations of interest have not been publicly available up to now because they are deemed to contain personal information which is exempt from release under freedom of information legislation.

17/07/2011

It is now July 2011 and strangely enough there is no mention of any declarations of interest on the IMB website or anywhere else. I’m waiting with anticipation as THAT will be very interesting! It will also be much more interesting when the Irish doctors, professors and universities have to declare how much they receive from the pharmaceutical industry. Now that, will be worth waiting for!